Schizophrenia Clinical Trial
— EVACOOfficial title:
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Verified date | March 2018 |
Source | Versailles Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.
Status | Completed |
Enrollment | 173 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Schizophrenia or schizoaffective disorder - Age > 18 years and < 65 years - Patient's state allows cognitive and neuropsychological assessment - Affiliated to a social security system (beneficiary or legal). - Informed consent signature (patients under guardianship may be included with written permission from their legal representative). Exclusion Criteria: - Alcohol dependence or current toxic - Electroconvulsivotherapy (less than 6 months) - Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary - Invalidating and uncorrected visual disorder - Invalidating and not paired hearing - Actually hospitalized under constraint - Patient not able to come to different evaluations, or who plan to change medical care in the following year |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont Ferrand | Clermont Ferrand | |
France | Hôpital Louis Mourier | Colombes | |
France | Hôpital Henri Mondor | Créteil | |
France | Centre Hospitalier de Versailles | Le Chesnay | |
France | Hôpital Sainte Marguerite | Marseille | |
France | CHRU de Montpellier | Montpellier | |
France | Centre Hospitalier Alpes Isère | Saint Egrève | |
France | CHU de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Versailles Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cognitive skills | Change in the aggregates (average) of standardized performance levels : z-scores of Theory of mind (V-COMICS, V-SIR, SPEX), z-scores of empathy (QCAE), z-scores of facial affect recognition (TREF), z-scores of metacognition (V-COMICS meta), Intelligence quotient (WAIS-III), z-scores of treatment speed, z-scores of memory spans, z-scores of verbal memory, z-scores of visual memory, z-scores of attention/vigilance, z-scores of divided attention, z-scores of executive functions. | Day 0, Month 12 | |
Secondary | Change in Functioning | Change in the aggregates (average) of standardized functioning assessment: z-scores of social functioning, z-scores of general functioning (PSPS), and z-scores of help acceptance subscales (M-SEQ) | Day 0, Month 12 | |
Secondary | Change in Psychotic symptoms | Change in the aggregates (average) of standardized symptomatology and clinical dimensions: z-scores of Schizophrenic syndromes, depressive syndrome and manic syndrome (PANSS), z-scores of observance scale (MARS/BARS), z-scores of insight (Birchwood), z-scores of antipsychotic medication doses | Day 0, Month 12 |
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